Lower riskMedical device recall · FDA · Published December 9, 2019
Abbott Medical Fast-Cath Trio Hemostasis Introducer Recall: Wrong Size Dilators
Abbott Medical recalls Fast-Cath Trio Hemostasis Introducers with 12F instead of 14F devices. This mismatch may cause improper use during medical procedures.
“Abbott Medical Fast-Cath Trio Hemostasis Introducer Recall: Wrong Size Dilators.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/66395-abbott-medical-fast-cath-trio-hemostasis-introducer-recall-wrong-size. Based on FDA recall #Z-0783-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0783-2020%22&limit=1).
The FDA announced on 2019-12-09 that Abbott Medical is recalling Fast-Cath Trio HEMOSTASIS INTRODUCER devices because they contain incorrect sizing components, according to the FDA.
How to tell if you have it
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
UPC: 15414734203903
Batch: 7133555
The hazard
The Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices, according to the FDA.
Context
GovInfoNow's records show Abbott Medical has 15 other recalls on record since 2019-10-14. Other recent recalls include the Abbott Medical Merlin PCS 365 recall on 2026-05-12, the Abbott Medical Eterna Spinal Cord Stimulation and Liberta RC Deep Brain Stimulation recall on 2025-10-06, and the Abbott Aveir DR Leadless Pacemaker Recall on 2025-02-15.
How to tell if you have this one
Check for the product name 'Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303'. The UDI code starts with (01)15414734203903(17)220731(10)7133555 and batch number 7133555.
Brand
Abbott Medical
Product
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Size
Verify the device has 14F dilators and sheaths as specified; if 12F is present, it is recalled.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 10 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide Distributed - US Nationwide in sates of: FL, PA, NY, TX, MI CA, IL, NE, AL, NV, including PR and the countries of: Malaysia, Korea, Paraguay” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Florida, Illinois, Michigan, Nebraska, Nevada, New York, Pennsylvania, Puerto Rico, Texas.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0783-2020 (December 9, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0783-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.